Impact of Oncotype DX® on Treatment Recommendation and Its Economic Evaluation Under the Brazilian Society Perspective

Breast Cancer Clinical Trial

Official title:

Impact of Oncotype DX® on Treatment Recommendation of for Early-stage Hormone Receptor-positive Breast Cancer and Its Economic Evaluation Under the Brazilian Society Perspective

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05100277
• Other study ID #: 1/2020
• Status: Completed
• Start date: August 8, 2018
• Est. completion date: February 4, 2019

Study information

• Verified date: December 2021
• Source: Hospital Perola Byington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

155 Pérola Byington Hospital patients presenting early stage luminal BC were submitted to Oncotype Dx® evaluation. Changes in treatment recommendations and costs were obtained from Pérola Byington Hospital. Oncotype DX® incorporation in the Brazilian Public Health System should be considered, as it results in high clinical impact for patient and high economic impact for health system, being a tool that safely and accurately delimits the subgroup of patients who really need AC.

Description:

Background: It is known that there is significant over administration (and under administration) of adjuvant chemotherapy (AC) when standard clinical parameters (SCP) are used for patients diagnosed with early stage RE+ breast cancer (BC). Although absolute clinical benefit of AC may be modest, its toxicity and economic burden is highly significant; therefore, selecting appropriate patients for AC remains an important issue. Oncotype DX® identifies high-risk patients who are likely to benefit from AC, which otherwise might not be identified through SCP and low-risk patients who will not benefit from AC, thus avoiding toxicities and inherent risks. This study aimed to evaluate the impact of the Oncotype DX® test on treatment decisions in N0 and N1 early-stage breast cancer patients at a Public Brazilian hospital and to estimate the incremental cost-effectiveness ratio (ICER) and budget impact (BI) of incorporating Oncotype DX® under the perspective of the Brazilian Society. Changes in treatment recommendations and costs will be obtained from Pérola Byington Hospital. Additional data will be obtained from literature. Medical costs (test, chemotherapy and adverse events), productivity loss, transportation and employment leave will be considered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Women = 18 years Early stage breast cancer, ER and/or PR positive with HER2 negative breast cancer. Exclusion Criteria: More than one operable primary breast tumor; Multifocal or multicentric tumors; 4 or more lymph node involvement; Metastatic breast cancer; Previous history of breast cancer; Invasive tumor <2 mm ; Performance status > 2 and / or other clinical factors that would make the patient a non-viable candidate for adjuvant chemotherapy; Previous hormonal or chemotherapy treatment; Current medical condition that would interfere with their ability to consent (psychiatric illness, for example)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• Oncotype DX® Assay
After surgery, tumoral tissue was used to perform Oncotype Dx®. Patients were evaluated and therapy recommendations - adjuvant chemotherapy (CT) plus hormone therapy (HT) or HT alone - were captured before and after revealing the test results. Results from TAILORx10 were used to guide decisions for or against CT for individual patients. Changes in treatment recommendations were obtained.

Other:
• Cost
Changes in treatment costs were estimated from Pérola Byington Hospital.

Locations

Country	Name	City	State
Brazil	Andre Mattar	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Perola Byington	Fleury Laboratory

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients whose choice of treatment is changed as a result of Oncotype Test Low risk	Changes based on initial clinical measures	up to 3 weeks
Primary	Economic evaluation	The costs of each scenario	up to 5 years